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Correspondence |

Iseganan Failure Due to the Wrong Pharmaceutical Technology FREE TO VIEW

Hendrik van Saene, MD; Joris van Saene, PhD; Luciano Silvestri, MD; Miguel de la Cal, MD; Richard Sarginson, MD; Durk Zandstra, MD
Author and Funding Information

Affiliations: University of Liverpool, Liverpool, UK,  Organon, Oss, the Netherlands,  Gorizia Hospital, Gorizia, Italy,  University Hospital Getafe, Madrid, Spain,  Royal Liverpool Children’s NHS Trust Alder Hey, Liverpool, UK,  Onze Lieve Vrouw Gasthuis, Amsterdam, the Netherlands

Correspondence to: Hendrik van Saene, MD, University of Liverpool, Medical Microbiology, Daulby St, Liverpool L693GA, UK; e-mail: rick.vansaene@rlc.nhs.uk



Chest. 2007;132(4):1412. doi:10.1378/chest.07-0172
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To the Editor:

We read the recent review by Craven in CHEST (July 2006),1entitled “Preventing Ventilator-Associated Pneumonia in Adults.” We enjoyed the article as it was up to date and balanced. In particular, we welcomed Dr. Craven’s conclusion on the iseganan failure that “these results raise several questions about iseganan efficacy and why it failed” as the original investigators did not attempt to explain their negative randomized controlled trial (RCT) findings.2 Iseganan did not impact pneumonia because the solution failed to decontaminate the oropharynx, as “there were no differences in reductions in total Gram-negative organisms and Staphylococcus aureus between test and control groups.”,2The failure to eradicate the oropharyngeal carrier state of these potential pathogens is probably due to the short contact time between iseganan in solution and the potential pathogens. Stoutenbeek et al3 were the first investigators to decontaminate the oropharynx of ventilated patients using a mucosa-adhesive paste (Orabase; Colgate; New York, NY) with 2% polymyxin E/tobramycin.

The major weakness of the iseganan RCT was its design because the control patients received placebo,4 which is unethical as they were put at unnecessary risk of pneumonia. The iseganan maneuver should have been compared with the best available clinical evidence, selective digestive decontamination.36 Two of the iseganan trial authors published selective digestive decontamination RCTs56 demonstrating pneumonia reduction.

We believe that clinical trials with end points of pneumonia/mortality should be preceded by a microbiological trial with an end point of the clearing the abnormal carrier state. Obviously, regular surveillance (ie, daily or, minimally, three times per week) is essential to assess the efficacy of a 2% iseganan gel as decontaminating agent. Throat surveillance in the iseganan RCT by Kollef et al2 was limited to swabbing at the start and end of the study, and when pneumonia developed in the patient.

We hope that iseganan will get another chance as this trial by Craven1 was ill-advised.

The authors have reported to the ACCP that no significant conflicts of interest exist with any companies/organizations whose products or services may be discussed in this article.

Craven, DE (2006) Preventing ventilator-associated pneumonia in adults.Chest130,251-260. [PubMed] [CrossRef]
 
Kollef, M, Pittet, D, Sanchez-Garcia, M, et al A randomized double-blind trial of iseganan in prevention of ventilator-associated pneumonia.Am J Respir Crit Care Med2006;173,91-97. [PubMed]
 
Stoutenbeek, CP, van Saene, HKF, Miranda, DR, et al The effect of oropharyngeal decontamination using topical non-absorbable antibiotics on the incidence of nosocomial respiratory tract infections in multiple trauma patients.J Trauma1987;27,357-364. [PubMed]
 
Emanuel, EJ, Miller, FG The ethics of placebo controlled trials: a middle ground.N Engl J Med2001;345,915-919. [PubMed]
 
Sanchez-Garcia, M, Cambronero Galache, JA, Lopez Diaz, J, et al Effectiveness and cost of selective decontamination of the digestive tract in critically ill intubated patients: a randomized, double-blind, placebo-controlled, multicenter trial.Am J Respir Crit Care Med1998;158,908-916. [PubMed]
 
Koeman, M, van der Ven, AJAM, Hak, E, et al Oral decontamination with chlorhexidine reduces the incidence of ventilator-associated pneumonia.Am J Respir Crit Care Med2006;173,1348-1355. [PubMed]
 

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References

Craven, DE (2006) Preventing ventilator-associated pneumonia in adults.Chest130,251-260. [PubMed] [CrossRef]
 
Kollef, M, Pittet, D, Sanchez-Garcia, M, et al A randomized double-blind trial of iseganan in prevention of ventilator-associated pneumonia.Am J Respir Crit Care Med2006;173,91-97. [PubMed]
 
Stoutenbeek, CP, van Saene, HKF, Miranda, DR, et al The effect of oropharyngeal decontamination using topical non-absorbable antibiotics on the incidence of nosocomial respiratory tract infections in multiple trauma patients.J Trauma1987;27,357-364. [PubMed]
 
Emanuel, EJ, Miller, FG The ethics of placebo controlled trials: a middle ground.N Engl J Med2001;345,915-919. [PubMed]
 
Sanchez-Garcia, M, Cambronero Galache, JA, Lopez Diaz, J, et al Effectiveness and cost of selective decontamination of the digestive tract in critically ill intubated patients: a randomized, double-blind, placebo-controlled, multicenter trial.Am J Respir Crit Care Med1998;158,908-916. [PubMed]
 
Koeman, M, van der Ven, AJAM, Hak, E, et al Oral decontamination with chlorhexidine reduces the incidence of ventilator-associated pneumonia.Am J Respir Crit Care Med2006;173,1348-1355. [PubMed]
 
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